REUSABLE BRONCHIAL BIOPSY FORCEPS

Forceps, Biopsy, Bronchoscope (non-rigid)

BALLARD MEDICAL PRODUCTS

The following data is part of a premarket notification filed by Ballard Medical Products with the FDA for Reusable Bronchial Biopsy Forceps.

Pre-market Notification Details

Device IDK022398
510k NumberK022398
Device Name:REUSABLE BRONCHIAL BIOPSY FORCEPS
ClassificationForceps, Biopsy, Bronchoscope (non-rigid)
Applicant BALLARD MEDICAL PRODUCTS 12050 LONE PEAK PKWY. Draper,  UT  84020
ContactCindy Ellis
CorrespondentCindy Ellis
BALLARD MEDICAL PRODUCTS 12050 LONE PEAK PKWY. Draper,  UT  84020
Product CodeBWH  
CFR Regulation Number874.4680 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-07-23
Decision Date2002-10-11
Summary:summary

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